Message 001
Communication from the Commission - TRIS/(2024) 1140
Directive (EU) 2015/1535
Notification: 2024/0231/BG
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20241140.EN
1. MSG 001 IND 2024 0231 BG EN 26-04-2024 BG NOTIF
2. Bulgaria
3A. Министерство на икономиката и индустрията
Дирекция "Техническа хармонизация"
ул. "Славянска" № 8, 1052 София
Tel.: +359 2 940 7336; +359 2 940 7522; +359 2 940 7480
FAX: +359 2 987 8952
e-mail: infopointBG@mi.government.bg
3B. Министерство на здравеопазването,
дирекция "Лекарствена политика"
пл. "Св. Неделя" № 5
1000 София
Тел.: +359 2 930 1298
email: vvasiyanova@mh.government.bg
4. 2024/0231/BG - C10P - Pharmaceuticals
5. Draft Order prohibiting the export of certain medicinal products
6. Medicinal products
7.
8. It shall be prohibited to export within the meaning of Article 217a(3) of the Law on Medicinal Products for Human Use of the following medicinal products which have received an authorisation pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency, and medicinal products with marketing authorisation issued under Article 26(1) of the Law on Medicinal Products for Human Use, classified according to an anatomical therapeutic chemical classification compliant to the requirements of the World Health Organisation (WHO) into pharmacological groups:
1. A10A “Insulins and analogues” – all medicinal products in the group;
2. A10B “Blood sugar lowering medicines excluding insulins” – a medicinal product with ATC code A10BJ06 in injection dosage form;
3. J01 ‘Anti-infectious medicinal products for systemic use’ – all medicinal products in the group in ‘powder for oral suspension’ and ‘granules for oral suspension’ pharmaceutical dose forms.
The prohibition applies from 17.05.2024 to 16.06.2024.
9. Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood sugar. Increased blood sugar, hyperglycemia, is the result of uncontrolled diabetes and over time leads to serious damage to many of the body’s systems, especially nerves and blood vessels.
Type 1 diabetes (known as insulin dependent) is characterised by insufficient insulin production and requires daily parenteral insulin administration.
Type 2 diabetes affects the way glucose in the body is absorbed and transformed into energy. This is a pathological condition in which cells either fail to respond normally to the hormone insulin or reduce the number of insulin receptors in response to hyperinsulinaemia.
The main danger in diabetes is its chronic complications. Diabetes leads to the development of damage to the eyes, kidneys, nervous system, cardiovascular diseases, brain strokes, pain in the lower extremities, etc.
In mid-April, by Order No RD-01-277/15.04.2024 of the Minister of Health was prohibited the export of medicinal products classified according to anatomical-therapeutic-chemical classification in accordance with the requirements of the World Health Organisation (WHO) in pharmacological groups:
1. A10A “Insulins and analogues” – all medicinal products in the group;
2. A10B “Blood sugar lowering medicines excluding insulins” – a medicinal product with ATC code A10BJ06 in injection dosage form;
3. J01 ‘Anti-infectious medicinal products for systemic use’ – all medicinal products in the group in ‘powder for oral suspension’ and ‘granules for oral suspension’ pharmaceutical dose forms.
In order to analyse the situation regarding their availability on the market and patients’ access to them, information from the Bulgarian Drug Agency (BDA) on the availability of medicinal products from pharmacological groups subject to the export ban in the warehouses of wholesalers and pharmacies, information from the Regional Health Inspectorates on checks carried out in open-type pharmacies on the availability of medicinal products, covering large and smaller settlements, as well as information from Information Services AD for prescribed and dispensed quantities of the medicinal products subject to the ban was requested.
Following an analysis of the data received from the above-mentioned institutions, there are indications of irregular deliveries/delays or refusals from wholesalers' warehouses for medicinal products from the following pharmacological groups: A10A “Insulins and analogues”, J01 “Anti-infectious medicinal products for systemic use” (in dosage forms “powder for oral suspension” and “granules for oral suspension”) and A10B “Blood sugar lowering medicines excluding insulins” – a medicinal product with ATC code A10BJ06 in injectable dosage form.
As regards medicinal products of the pharmacological group – A10A “Insulins and analogues” it is noted that one of the insulins has irregular supply/delay or refusal in warehouses in more than 2/3 of all provinces in the country. Seven types of insulins from this pharmacological group have irregular supplies/delay or refusal in warehouses in nearly ½ of all districts in the country.
Following an analysis of the information received from the BDA, comparable to the information on the average monthly consumption of medicinal products by health insurance contributors, published on the website of the National Health Insurance Fund (NHIF), it was found that there was a difficulty in the supply of both pharmacies and patients with the medicinal products of the pharmacological group – A10A “Insulins and analogues”.
As regards the medicinal product with INN Semaglutide:
The checks carried out by the Regional Health Inspectorates, as well as after an analysis of the information received from the BDA and the average monthly consumption of the medicinal product, difficulties in the provision of the medicinal product in pharmacies in the following provinces have been revealed: Blagoevgrad, Burgas, Varna, Lovech, Razgrad, Haskovo.
As regards medicinal products of the following pharmacological group: J01 “Anti-infectious medicinal products for systemic use” – all medicinal products in the group in pharmaceutical forms “powder for oral suspension” and “granules for oral suspension”:
After a review and analysis of the information received, it was found that the greatest delay, irregularity in supplies, including refusal from the warehouses of wholesalers has been found for medicinal products belonging to INN: Amoxicilline, clavulanic acid – seven medicinal products out of 29 with reports of bottlenecks in supply. 86 % of the districts in the country reported refusal and/or irregular supplies of one of these seven medicinal products. As regards the remaining six medicines, there have been delays or refusals for supply in between 54 % and 32 % of the districts in the country.
Although the mechanisms laid down in the legislation to restrict the export of medicinal products laid down in Chapter Nine “b” “Export of Medicinal Products”. Specialised electronic system for follow-up and analysis of medicinal products” in the Act on Medicinal Products in Human Medicine, as it could be noted from the analysis of the data received from the above-mentioned institutions, a shortage of medicinal products continues to be observed. Proof of this is the continued receipt of signals of lack in the pharmacy network of these medicines received at the Ministry of Health, and one of the possible reasons for this shortage is that these products are being exported from the territory of the Republic of Bulgaria to other countries in quantities that create conditions for a potential shortage of these medicinal products on the Bulgarian market.
Regardless of the legal nature of the activity carried out, the export of medicinal products used for the treatment of diabetes and of antibacterial medicinal products for systemic use, as well as the observed delays in the supply, disturbs the balance between the medicinal products supplied on the territory of the country and the increased needs thereof to meet the health needs of the population.
Following an in-depth analysis of the current situation with regard to the availability of the above-mentioned groups of medicinal products and the information provided above, the need to introduce an export ban of the aforementioned groups of medicinal products has been identified.
Moreover, by setting the mentioned export ban period of the medicinal products, a balance will be achieved between the objective of the measure applied – the provision of sufficient quantity of those medicinal products necessary for the treatment of the Bulgarian patients, the protection of their health and ensuring the continuity of their medicinal therapy, on one hand, and on the other hand, non-violation for a long period of time of the right of economic operators to carry out the free movement of the goods in which they trade – in this case medicinal products.
The objective sought – to provide the Bulgarian pharmaceutical market with sufficient medicinal products to meet the needs of the population, should be proportionate to the potential economic benefits that would accrue to the holders of marketing authorisations for medicinal products if they were able to export the described products during the period in question. The prohibition period introduced does not violate the principle of proportionality laid down in the Administrative Procedure Code, the main purpose of which is that the administrative act and its implementation may not affect rights and legitimate interests to a greater extent than necessary for the purpose for which the act is issued (Article 6(2) of the APC).
The duration of the prohibition, as well as the specific medicinal products, have been determined in strict compliance with the principle of proportionality, in order to protect the health of the population and in compliance with the prohibition of arbitrary discrimination or disguised restriction on trade between Member States referred to in Article 36 of the Treaty on the Functioning of the European Union.
10. References to the basic texts: There is no main text
11. Yes
12. Reports have continued to come in about the unavailability in the pharmacies of insulin, which is vital for the treatment of diabetes. One of the reasons for this unavailability is that these products are exported from Bulgaria to other countries in quantities that create conditions for potential shortages on the Bulgarian market. Data on irregular supplies/delays or refusals from the warehouses of wholesalers for these medicines, including data from the BDA, were reported, comparable to the data on the average monthly consumption of medicinal products by the health insured persons, published by the NHIF, on difficulty in supplying to pharmacies and patients. One of the insulins has been supplied irregularly or its supply has been refused in warehouses in more than 2/3 of all districts in the country. Seven insulins in this pharmacological group have irregular supplies/delays or refusals in warehouses in nearly ½ of all districts. The analysis also shows that the greatest delay exists for medicines belonging to INN: Amoxicilline, clavulanic acid – seven medicinal products out of 29 with reports of bottlenecks in supply. In the system for follow-up and analysis, a shortage of medicinal products continues to be observed. The need for the immediate measure has been identified following an in-depth analysis of the current situation with the availability of medicines and in the light of the data from the system. The measure will achieve timely and adequate provision of these medicinal products for the treatment of the Bulgarian patients, which will ensure the protection of their health and will ensure secure continuity of their drug therapy.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
